Contract Manufacturing Organizations (CMOs) face constant challenges in the course of developing and manufacturing new pharmaceuticals or other products. And unfortunately, many drug development processes suffer from planning problems, as well as delays in development, unforeseen activities, cost overruns, and other losses. Many problems cannot be prevented, yet many of these shortcomings sometimes are the result of poor project planning in addressing the complexities of today’s projects.
While there are many unknowns in the development of New Chemical Entities (NCEs), Active Pharmaceutical Ingredient (API) manufacturing and custom chemistry projects, knowing where your project stands should not be one of them. Effective project management can help to make sure projects not only stay on track and on budget, but it also keeps all stakeholders informed every step of the way. This article will provide tips to help sponsors work together with their CMOs to keep projects on track.
One of the truism in any chemical product development project is that you don’t know how to get there unless you know where you are going. Because of this, it is critical that project managers understand the requirements, volumes, timelines and regulatory strategy for that particular compound. The project manager role comes with the need to have an acute understanding of the goals of the program. Everyone has his own unique and highly individual way of getting things done, but the mechanics of a successful project often are often shared by many successful project managers.
Below are the four key steps and considerations in ensuring effective project management:
Conduct a kick-off-meeting. To bring together different functional groups from the sponsor’s side, as well as the CMO’s, including analytical, regulatory and R&D experts, to define roles and responsibilities, set up a communication schedule and outline the various activities that need to take place. This meeting will set the tone for the entire program and reinforces the importance of communication throughout each step of the process. It should also include scientists assigned to the project and the sponsor’s business leaders.
Prior to this meeting, it’s important for the project manager to review the original proposal and make sure there is no disconnect. Likewise, make sure everyone is on the same page. Business departments and technical ones are not always in sync with their goals and drivers, so it’s important to talk this out. Also, between the time the proposal has been submitted and when it is approved we often see goals, objectives, technologies and quantities change, which all must be realigned in the proposal.
Here at PCI Synthesis, once a regular weekly meeting time is established, we provide a weekly agenda and minutes tracker to make sure everyone is up-to-date on what was discussed and resulting action items.
The role of project management in any API manufacturing program is never an easy one for CMOs, yet critical to the successful outcome. Using key tools and techniques, such as Gantt charts, timelines and reporting documents are helpful in making sure projects stay on track, yet none of these tools can replace the most effective ones: open and transparent communication between CMOs and their sponsors.
Our blog has lots of content about how to work more effectively with CMOs. Check out Process Research Best Practices, which describes ways to lower drug development costs and How to Keep CMO Costs Down During the Process Optimization Stage of Drug Development.